Revisable orthopedic anchor and methods of use

ABSTRACT

A revisable orthopedic anchor and method of use for removably securing an anchor in bone, such as compromised or degenerated bone, is described herein. In one embodiment, the anchor makes use of dual probes and vector divergence of the distal tips of the probes to achieve superior bone purchase and pull-out resistance. In such an embodiment, the probes can be inserted one at a time into a hole formed in, for example, the pedicle bone. After the probes are inserted and joined at the proximal end, they have a greater pull-out resistance than a threaded anchor. Removing the anchor involves separating the proximal heads and reversing the implantation process. As a result of the unique bone anchor design disclosed herein, the devices and methods of the present invention allow for less complicated implantation and removal of orthopedic anchors, all while providing enhanced bone purchase when implanted in a patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/858,866, filed on Sep. 18, 2015, and entitled “REVISABLE ORTHOPEDICANCHOR AND METHODS OF USE.” U.S. application Ser. No. 14/858,866 is acontinuation of U.S. application Ser. No. 13/222,389, filed on Aug. 31,2011, entitled “REVISABLE ORTHOPEDIC ANCHOR AND METHODS OF USE,” and nowissued as U.S. Pat. No. 9,173,683. Each of these applications is herebyincorporated by reference in its entirety.

FIELD

This invention is related to bone anchors for use in orthopedic surgeryand, in particular, to devices and methods for implanting an anchor inbone such that the anchor provides enhanced bone purchase during use aswell as easy removal.

BACKGROUND

Bone in human and other mammal bodies is generally classified into twotypes, cortical bone, also known as compact bone, and trabecular bone,also known as cancellous or spongy bone. Cortical bone is much denserthan trabecular bone with a porosity ranging between 5% and 10%.Cortical bone is found primarily in the shaft of long bones and formsthe outer shell around trabecular bone at the end of joints and thevertebrae.

In the vertebrae, each bone is generally heart shaped, with spinous,inferior and superior processes joined to the vertebral body viaopposing pedicles. To stabilize or fix deformities in the spine,implantable medical devices, known as spinal fixation devices, can beemployed between adjacent vertebrae. These devices can be attached tothe vertebrae using screws inserted through the pedicles (i.e., using“pedicle screws”) and other osseous structures such as the lamina andfacet joints.

The outer shell of the pedicles is formed of dense cortical bone, whichsurrounds spongier trabecular bone. As mentioned above, trabecular boneis normally less dense than cortical bone. Degenerative conditions,which can result from diseases such as osteoporosis or injury, can causethe trabecular bone to weaken or degrade even further.

As a result of the lower density of the trabecular or compromised bone,screws of all sizes can loosen or shift position after implantation.Prior art attempts to secure bone screws in the pedicles includefeatures to prevent loosening of the screws. These features can includedeflectable wings that push outwardly against the bone, ortoggle-bolt-like fittings that rotate once inside the cortical boneshell to prevent removal therefrom. Other prior art systems make use ofcement or other binding agent to secure the bone screw inside of thepedicle.

These prior art solutions, however, are not without potential drawbacks.For example, prior art implementations are designed to provide permanentfixation of the bone screw within the pedicle or other bone.Accordingly, removal of these components requires a complicated andoftentimes invasive procedure. In addition, some prior art solutionsutilize traditional threaded screws that require pre-implantationoperations to correctly drill and tap a hole through the bone.

Finally, in certain situations it can be desirable to utilizeradiolucent materials to avoid interference with medical imagingtechnologies. Prior art implementations, however, often utilize metalbone screws that are substantially radiopaque. This can be becauseradiolucent materials (e.g., any of various polymer-based materials) areoften not suitable for creating fine features like threading on a screw.

Hence, there is a need in the art for a device and method for securingan anchor in degenerated bone such that the anchor exhibits enhancedbone purchase while remaining easy to remove after use. Further, thereis a need in the art to design these anchors such that they can beformed from radiolucent materials to prevent interference with medicalimaging technologies.

SUMMARY

To overcome the above and other drawbacks of conventional systems, thepresent invention provides a revisable orthopedic anchor and method ofuse for removably securing an anchor in degenerated bone. In oneembodiment, the anchor makes use of dual probes and vector divergence ofthe distal tips of the probes to achieve superior bone purchase. In saidembodiment, the probes can be inserted one at a time into a hole formedin, for example, the pedicle bone. After the probes are inserted andjoined at the proximal end, they have a greater pull-out resistance thana threaded anchor. Removing the anchor involves separating the proximalheads and reversing the implantation process. As a result of the uniquedesigns disclosed herein, the devices and methods of the presentinvention allow for less complicated implantation and removal oforthopedic anchors, all while providing enhanced bone purchase onceimplanted in a patient.

In one aspect of the invention, a bone anchor is provided that includesa first probe component in the form of an elongate member having aproximal head and a distal tip. The first probe component furtherincludes a bone engaging edge having a plurality of barbs, an opposededge, an external surface, and an opposed internal surface having aguide shoulder formed thereon. The bone anchor also includes a secondprobe component in the form of an elongate member having a proximal headand a distal tip. The second probe component similarly includes a boneengaging edge having a plurality of barbs, a mating edge having aprofile complimentary to the guide shoulder and being configured to beseated along the guide shoulder, an external surface, and an opposedinternal surface. Optionally, the mating edge of the second probe memberis curved. The first and second probe components are configured to beassembled to form a bone anchor such that the barbed bone engaging edgesof the first and second probe components are disposed opposite to oneanother, the mating edge of the second probe component is seated alongthe guide shoulder of the first probe component, and the distal tip ofeach probe component diverges away from a central longitudinal axis ofthe anchor. The first and second probe members can optionally be curvedelongate members.

The above-described bone anchor can include a variety of furtherfeatures or modifications. For example, in some embodiments, theexternal surfaces of the first probe component and the second probecomponent can be convex. When the probes are assembled to form a boneanchor, the resulting cross-sectional shape can better adapt to thenon-circular anthropometrics of the pedicle or other bone.

In other embodiments, the internal surfaces of the first probe componentand the second probe component can be substantially linear. Linearinternal surfaces provide for easy and secure mating between the firstand second probe components when assembled to form a bone anchor. Instill other embodiments, alternative profiles can be used, including,for example, convex/concave shapes, interlocking ridges (i.e., tongueand groove surfaces), complementary diagonals, etc.

The bone anchor can further include a crimp head configured to retainthe proximal heads of the first probe component and the second probecomponent in a fixed relationship with each other. Such a crimp head canprevent the two probe components from separating after implantation. Asexplained below, maintaining the proximal heads in a fixed relationshipwith each other can be important to provide the bone anchor with itssuperior resistance to removal.

In certain embodiments, the proximal head of the first probe componentand the second probe component can include a recess formed thereinconfigured to seat a spinal fixation element. The seat formed by theprobe components, in combination with a crimp head that forces thespinal fixation element into the seat, can securely attach a vertebralbody to a spinal fixation element.

In other embodiments, the bone anchor can include a polyaxial receivinghead configured to retain the proximal heads of the first probecomponent and the second probe component in a fixed relationship witheach other. In these embodiments, the polyaxial receiving head replacesthe above-mentioned crimp head to both hold the probe componentstogether at their proximal ends and to secure a spinal fixation elementto the bone anchor.

In still other embodiments, each of the first probe component and thesecond probe component can include a rod section joined to the proximalhead thereof. Each rod section can be joined to form a spinal fixationelement that can, in turn, be attached to adjacent bone anchors. Thebone anchor can also include a crimp head configured to retain theproximal heads and rod sections of the first probe component and thesecond probe component in a fixed relationship with each other.

In certain embodiments, the bone anchor can include an implantconfigured to fuse two vertebral bodies together. The implant caninclude at least one lumen formed therein and configured to receive thefirst probe component and the second probe component.

In some embodiments, the implant can include a set screw configured toengage a threaded lumen formed in the implant to secure the first probecomponent and the second probe component in relation to each other andthe implant.

The first and second probe components, and associated rod sections, ifany, can be formed from a variety of materials. For example, the probecomponents and rod sections can be formed from any of titanium, atitanium alloy, polyether ether ketone (PEEK), and reinforced PEEK. Thecrimp head, polyaxial receiving head, and implant can each be formedfrom similar biocompatible materials.

In some embodiments, the first probe component and the second probecomponent are formed from a radiolucent material. Forming the probecomponents from radiolucent materials prevents the implanted anchor frominterfering with medical imaging technologies (e.g., X-rays, etc.).

In another aspect of the invention, an implantable bone anchor isprovided including an elongate member having a proximal head with afixation element receiving seat and dual divergent distal tips. The boneanchor further includes opposed bone engaging edges having a pluralityof barbs formed thereon. The bone anchor can be formed of separatematable probe components and each probe component has one of thedivergent distal tips.

In some embodiments, each probe component is curved along its lengthfrom the proximal head to the divergent distal tip. This curve, combinedwith the dual divergent tips, results in an anchor that is wider at itsdistal end than at its proximal end. This configuration allows theanchor to resist being pulled out of the bone.

In some other embodiments, each probe component is mated to the otheralong at least a portion of an internal surface that is opposed to oneof the bone engaging edges. As a result, the bone engaging edges of eachprobe component oppose each other and are configured to engage bone uponimplantation. The bone engaging edges can include barbs or otherprotrusions configured to interface with a bone wall. In someembodiments, these barbs can be directionally oriented to allow travelin one direction (e.g., insertion), but oppose travel in an oppositedirection (e.g., removal).

In a third aspect of the invention, a method of anchoring an implant tobone is provided comprising the steps of inserting a first probe memberinto a cavity formed in bone, where the first probe member is a curved,elongate member having a distal tip and a proximal head. The methodfurther includes the step of inserting a second probe member into thecavity adjacent to the first probe member where the second probe memberis a curved, elongate member having a distal tip and a proximal head,and where the first and second probe members mate to one another suchthat the heads of the first and second probe members are aligned and thedistal tips of the first and second probe members diverge.

In some embodiments, the method step of inserting the second probemember includes sliding the second probe member along a guide shoulderformed in the first probe member to properly align the first probemember and the second probe member in the cavity.

In other embodiments, the method can further include the step ofapplying a crimp head to the proximal heads of the first probe memberand the second probe member to retain the proximal heads in relation toeach other.

In still other embodiments, the first probe member and the second probemember can each further include a rod section connected to the proximalhead. The method can also include the step of aligning the rod sectionsof the first probe member and the second probe member to assemble aspinal fixation element. Still further, the method can include the stepof applying a crimp head to retain the proximal heads and rod sectionsof the first probe member and the second probe member in relation toeach other.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a perspective view of one embodiment of a bone anchor of thepresent invention comprising two probe components;

FIG. 1A is a perspective view of the first probe component of the boneanchor in FIG. 1;

FIG. 2 is a perspective view of another embodiment of a bone anchor ofthe present invention having a flat top surface on its proximal end;

FIG. 2A is an alternate perspective view of the bone anchor in FIG. 2;

FIG. 3 is a perspective view of a crimp head configured to retain theproximal heads of the first and second probe components in a fixedrelationship with each other and receive a spinal fixation element;

FIG. 4 is a perspective view of the bone anchor of FIG. 1, including thecrimp head in FIG. 3;

FIG. 5 is a perspective view of the bone anchor in FIG. 2, including apolyaxial receiving head configured to retain the proximal heads of thefirst and second probe components in a fixed relationship with eachother and receive a spinal fixation element;

FIG. 6 is a perspective view of the bone anchor in FIG. 5 with thepolyaxial receiving head hidden to reveal a spinal fixation element seatadapter and set screw;

FIG. 7 is a cross-sectional view of the bone anchor in FIG. 5 implantedin a pedicle bone of a patient;

FIG. 8 is a cross-sectional view of the bone anchor in FIG. 7, takenalong line A-A in FIG. 7, showing the complementary non-circular shapeof the pedicle bone and probe components;

FIG. 9 is a perspective view of an embodiment of an implant of thepresent invention configured to fuse two vertebral bodies togetherincluding at least one bone anchor and a set screw;

FIG. 10 is an alternate perspective view of the implant in FIG. 9showing lumens configured to receive first and second probe components,as well as a threaded lumen configured to receive a set screw;

FIG. 11 is a perspective view of the implant in FIG. 9 with the implantbody hidden to reveal the orientation and interaction between the boneanchors and the set screw;

FIG. 12 is a perspective view of the implant in FIG. 9 in positionbetween two vertebral bodies with implanted bone anchors shown inphantom;

FIG. 13 is a perspective view of an embodiment of a bone anchor of thepresent invention wherein each probe component includes a rod sectionconnected thereto that forms a spinal fixation element when alignedtogether;

FIG. 14 is an alternate perspective view of the bone anchor in FIG. 13showing the non-circular cross-sectional shape of the rod sections;

FIG. 15 is a perspective view of the internal surface of the first probecomponent of the bone anchor in FIG. 13;

FIG. 16 is a perspective view of the internal surface of the secondprobe component of the bone anchor in FIG. 13;

FIG. 17 is a perspective view of the bone anchor in FIG. 13 implanted ina vertebral body and including a crimp head to retain the proximal headsand rod sections of each probe component in relation to each other;

FIG. 18 is a perspective view of the bone anchor in FIG. 17 showing thecrimp head retaining the proximal heads and rod sections of each probecomponent in relation to each other;

FIG. 19 is an alternate perspective view of the crimp head in FIG. 18;

FIG. 20 is a perspective view of an embodiment of a spinal fixationassembly of the present invention including various embodiments of thebone anchors disclosed herein;

FIG. 21 is a cross-sectional view of an embodiment of a bone anchor ofthe present invention configured to function as a suture anchor;

FIG. 22 is a front view of an embodiment of a bone anchor of the presentinvention including a rod section connected to each probe component anda hinge area that allows each probe component to be folded andintroduced through, for example, a laparoscopic port; and

FIG. 23 is a flow diagram illustrating an embodiment of a method of thepresent invention.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the devices and methodsdisclosed herein. One or more examples of these embodiments areillustrated in the accompanying drawings. Those skilled in the art willunderstand that the devices and methods specifically described hereinand illustrated in the accompanying drawings are non-limiting exemplaryembodiments and that the scope of the present invention is definedsolely by the claims. The features illustrated or described inconnection with one exemplary embodiment may be combined with thefeatures of other embodiments. Such modifications and variations areintended to be included within the scope of the present invention.

In one aspect of the invention, a bone anchor is provided that includestwo probe components configured to be assembled to form a complete boneanchor. Each probe component can be in the form of an elongate memberhaving a proximal head and a distal tip. A first probe component canhave a bone engaging edge, an opposed edge, an external surface, and anopposed internal surface having a guide shoulder formed thereon. Asecond probe component can have a bone engaging edge, a mating edge, anexternal surface, and an opposed internal surface. The mating edge ofthe second probe component can have a profile complementary to the guideshoulder of the first probe component and be configured to be seatedalong the guide shoulder. While the first and second probe members areillustrated herein as curved, one skilled in the art will appreciatethat they may be linear and non-curved. Similarly, the mating edge ofthe second probe component is illustrated herein as having a curvedprofile, but it may alternatively be linear.

In use, the distal tips of the first and second probe components can beinserted sequentially into a small hole formed in, for example, apedicle bone. Once inserted into the pedicle bone, the proximal heads ofthe first and second probe components can be joined together such thatbone engaging edges of the first and second probe components aredisposed opposite to one another, the mating edge of the second probecomponent can be seated along the guide shoulder of the first probecomponent, and the distal tips of the first and second probe componentscan diverge away from a central longitudinal axis of the bone anchor.The divergent distal tips of the bone anchor can allow the curved boneengaging surfaces to interface with, for example, the more densecortical bone that forms the outer shell of the pedicle, therebyproviding greater pull-out resistance than a traditional bone screw.

FIGS. 1, 1A, 2, and 2A illustrate a bone anchor 100 of the presentinvention comprising a first probe component 102 and a second probecomponent 104. The probe components 102, 104 are separate and designedto be mated together, for example, in the orientation shown in FIG. 1.In such an orientation, the proximal head 106 of the first probecomponent 102 and the proximal head 108 of the second probe component104 are aligned while the distal tip 110 of the first probe component102 and the distal tip 112 of the second probe component 104 divergeaway from a central longitudinal axis 114 of the bone anchor.

The first probe component, shown in isolation in FIG. 1A, can include abone engaging edge 116 having a plurality of barbs 118 formed thereon.Barbs 118 can be formed in a variety of shapes but, in an exemplaryembodiment, the barbs can be formed with a one-way directional slant.The directional slant of the barbs allows advancement of the probecomponent into bone, but resists its removal. The first probe componentcan also include an opposed edge 120, which can have a smooth curvedprofile. One skilled in the art will appreciate that the barbs mayadditionally include, or they may be formed from, teeth, porous bonein-growth surfaces, and micro- or nano-features.

The first probe component can also include an internal surface 122configured to interface with a portion of the second probe component104. The internal surface 122 can be substantially linear to provide aplanar surface to interface with the second probe component 104. Theinternal surface 122 can also include a guide shoulder 124 formedthereon that is also configured to interface with a portion of thesecond probe component 104. The guide shoulder 124 can be formed in avariety of shapes depending on the desired geometry of the bone anchor.In an exemplary embodiment, the guide shoulder 124 forms a diagonallyextending curve across the internal surface 122 of the first probecomponent 102. In such a configuration, the guide shoulder 124 cangradually urge the distal tip 112 of the second probe component 104 todiverge from the distal tip 110 of the first probe component 102 as thesecond probe component is advanced down the length of the first probecomponent along the internal surface 122. Although not illustrated, theinternal surface 122 may alternatively include one or more featuresformed thereon that are configured to mate with complementary featuresof the internal surface 206 of the second probe component 104.

The first probe component 102 can further include an external surface202, as shown in FIG. 2A. The external surface 202 can have a variety ofprofiles according to the geometry of the intended implantation site. Inan exemplary embodiment, external surface 202 has a convex profile toadapt to the non-circular geometry of the pedicle bone, as discussedbelow.

Referring back to FIG. 1A, the first probe component 102 can include aproximal head 106 at its proximal end. Proximal head 106 can be formedin a variety of shapes and sizes according to the requirements of anyreceiving heads or other accessories to be attached to the bone anchor.In one embodiment, proximal head 106 can include a recess 126 formedtherein and configured to form a fixation element receiving seat 128(shown in FIG. 1) when combined with a complementary recess formed inthe proximal head 108 of second probe component 104.

In other embodiments, proximal heads 106, 108 of the first and secondprobe components 102, 104 can have alternate geometries. For example,and as illustrated in FIGS. 2 and 2A, proximal heads 106, 108 can eachinclude a flat surface 204, 208, or any other type of surface configuredto interface with a receiving head assembly. Proximal heads 106, 108 offirst and second probe components can also have a bulb-shape on theirouter surfaces to allow polyaxial movement of attached receiving headassemblies having a socket-shaped cavity to receive the proximal heads106, 108.

FIGS. 1 and 1A also illustrate a receiving head attachment portion 130that can be included in the first probe component 102. Receiving headattachment portion 130 can be located distally from the proximal head106 and can be configured to receive a mating feature from a receivinghead or other accessory. In an exemplary embodiment, receiving headattachment portion 130 can be a narrowed section of the first probecomponent 102.

FIGS. 1, 2, and 2A also illustrate an exemplary embodiment of the secondprobe component 104. The second probe component 104 can have severalfeatures in common with the first probe component 102. These can includea bone engaging surface 132 having a plurality of barbs 118 formedthereon and an external surface 134 that can have a similar profile tothe external surface 202 of first probe component 102 (e.g., a convexsurface profile). As shown in FIG. 2A, the second probe component 104can include an internal surface 206 opposed from external surface 134.The internal surface 206 can have a substantially linear surface profilein order to interface with the substantially linear internal surface 122of the first probe component 102. Alternatively, however, and as notedabove, the internal surface 206 can have features (not shown) that areconfigured to mate with complementary features (also not shown) of theinternal surface 122.

Referring back to FIGS. 1 and 2, the second probe component 104 caninclude a mating edge 136 opposed from the bone engaging edge 132. Themating edge 136 can have a profile complementary to the profile of theguide shoulder 124. In an exemplary embodiment, the mating edge 136 hasa curved profile matching the curve of guide shoulder 124. Thecomplementary profiles allow the mating edge 136 to slide along theguide shoulder 124 as the second probe component 104 is implantedadjacent to the first probe component 102.

The second probe component 104 can also include similar components atits proximal end as the first probe component 102. For example, thesecond probe component can include a proximal head 108 configured tointerface with a variety of spinal fixation components. Proximal head108 can include, for example, a recess 138 formed therein that, incombination with recess 126 of the first probe component 102, can form afixation element receiving seat 128. Alternatively, proximal head 108can include a flat surface 208, as shown in FIG. 2. The second probecomponent 104 can also include a receiving head attachment portion 140similar to the receiving head attachment portion 130 of the first probecomponent 102.

The first and second probe components can be formed from a variety ofbiocompatible materials suitable for implantation in a patient. Thesematerials include, for example, metals such as titanium and titaniumalloys, as well as polymers such as polyether ether ketone (PEEK) andreinforced PEEK. The design of the bone anchor of the present inventioncan be particularly well suited to the use of polymer-based materials.This is in contrast to traditional bone screw designs that have finethread forms that cannot be reliably created with polymers. Anotheradvantage of utilizing polymers like PEEK is the radiolucency of thesematerials. Unlike prior art metal bone screws, X-Ray and other medicalimaging technologies can see through bone anchors formed from theseradiolucent materials, providing medical professionals with a betterimage of the surrounding bone structure.

The first and second probe components can also be formed in a variety ofsizes suited to the particular implantation site. In exemplaryembodiments, the bone anchors are implanted in the pedicle bones ofhuman vertebrae and are therefore sized accordingly. As discussed below,however, bone anchors of the present invention can be utilized in manydifferent operations where tissue or implants need to be secured tobone. Variations on the size of the bone anchors to accommodatedifferent implantation site geometries are considered within the scopeof the invention.

As the foregoing description of the first and second probe componentsillustrates, an inventive aspect of the bone anchor disclosed herein isthe ability to insert the first probe component 102 into a cavity formedin a bone, then insert the second probe component 104 and utilize thefirst probe component to aid in positioning the second probe component.This can be accomplished, for example, through the interaction of theguide shoulder 124 of the first probe component 102 and the mating edge136 of the second probe component. After both probe components areimplanted in the bone cavity, the proximal heads of the first and secondprobe components can be secured together to lock the probe components inthe orientation shown in FIGS. 1 and 2.

FIG. 3 illustrates an exemplary embodiment of a crimp head 300 that canbe used to secure the proximal heads 106, 108 of the first and secondprobe components 102, 104 together. Crimp head 300 includes an archportion 302 that extends between two sets of clamping arms 304. Crimphead 300 can further include recesses 306 configured to receive thebulb-shaped proximal heads 106, 108 of the first and second probecomponents 102, 104.

FIG. 4 illustrates crimp head 300 in position over the first and secondprobe components shown in FIG. 1. In FIG. 4, crimp head 300 is shown inan un-compressed state in which there is a small amount of clearancebetween the clamping arms 304 and the receiving head attachment portion130. There is also a small amount of clearance between the recesses 306and the proximal heads 106, 108 of the first and second probe components102, 104. This is done so that crimp head 300 can be placed over the topof the proximal head 106, 108 of first and second probe components 102,104 without encountering resistance. To secure the crimp head 300 (andthereby secure the proximal heads 106, 108 in a fixed relationship witheach other) a crimping tool (not shown) or other device suitable toprovide compressive force to the clamping arms 304 can be used toposition the clamping arms securely on the receiving head attachmentportion 130, 140 of the first and second probe components.

FIG. 4 also illustrates that the arch portion 302 of crimp head 300, incombination with fixation element receiving seat 128, forms a closedlumen that can be used to secure a spinal fixation element to the bone.As a result, the bone anchor and crimp head of the present invention canbe used to anchor spinal fixation elements to the vertebrae in place oftraditional bone screws. An exemplary prior art system of spinalfixation is disclosed in U.S. Pat. No. 7,527,638 to Anderson et al.,which is hereby incorporated by reference in its entirety.

Crimp head 300 can be formed from any of the same biocompatiblematerials mentioned above with respect to the first and second probecomponents. However, consideration should be given to the ability of thematerial to hold its shape under stress once crimped in position. In anexemplary embodiment, the crimp head 300 can be formed from a malleablematerial, such as titanium or a titanium alloy, in order to both allowdeformation into the desired shape and to provide the necessary rigidityafter implantation.

The crimp head 300 is one embodiment of a receiving head assembly thatcan be attached to the bone anchor of the present invention. FIG. 5illustrates another suitable receiving head assembly embodiment in theform of a polyaxial receiving head. Polyaxial receiving head 500 issimilar to polyaxial receiving heads known in the prior art. U.S. Pat.No. 7,682,377 to Konieczynski et al., which is hereby incorporated byreference in its entirety, illustrates an exemplary prior art polyaxialreceiving head. The polyaxial receiving head 500 can include a U-shapedtransverse passage and a lumen for receiving the proximal heads 106, 108of first and second probe components 102, 104. Polyaxial receiving head500 can also include a spinal fixation element seat adapter 502 for usein embodiments having a flat surface 204, 208 on proximal heads 106,108, as well as a set screw 504 that can be used to secure a spinalfixation element within the U-shaped transverse passage. FIG. 6illustrates an alternate view of the bone anchor in FIG. 5 with thepolyaxial receiving head hidden to better depict the spinal fixationelement seat adapter 502 and set screw 504.

Having described exemplary components of the present invention, FIG. 7depicts an exemplary bone anchor implanted within the pedicle bone of apatient's vertebrae in order to better illustrate each component'sfunction. The partial cross section of the vertebrae 700 shows the outerlayer of dense cortical bone 702 and the inner core of less densetrabecular bone 704. Implanted through the anterior portion of thepedicle bone 706 is bone anchor 100 including polyaxial receiving head500.

Bone anchor 100 is able to achieve superior bone purchase in the pedicle706 as a result of the curved shape of the first and second probecomponents 102, 104 and the associated divergent distal tips 110, 112.As FIG. 7 illustrates, the curved shape of the first and second probecomponents 102, 104 allows the bone engaging surfaces 116, 132 of thefirst and second probe components to interface with the strongercortical bone forming the posterior rim 708 of the vertebral body. Inaddition, the combined probe width 710, which is measured as thedistance between the divergent distal tips 110, 112 of the first andsecond probe components, is greater than the width 712 of the pediclebone 706. As a result, the bone anchor 100 cannot be removed through thepedicle 706 so long as the polyaxial receiving head 500 retains theproximal ends 106, 108 of the first and second probe components 102, 104in a fixed relationship with each other.

However, the width between divergent tips is not the only manner inwhich the bone anchor of the present invention utilizes anatomicalgeometry to its advantage. FIG. 8 illustrates a cross sectional viewalong the line A-A in FIG. 7. The figure illustrates that pedicle bone706 (again, comprising a shell of cortical bone 702 and a core oftrabecular bone 704) has a non-circular cross-sectional profile. Manyknown bone screws utilize circular cross sectional shapes, mostly due tolimitations of processing the materials used to form the screws. Formingthe first and second probe components 102, 104 of the present inventionfrom polymer-based materials such as PEEK or reinforced PEEK allows forthe creation of non-circular geometries that can better fill—and thusbetter anchor within—the pedicle bone 706 or other bone havingnon-circular geometry.

In another embodiment, shown in FIG. 9, the bone anchor of the presentinvention includes an implant 900 configured to fuse two vertebralbodies together. The implant 900 can be used to replace a degenerated orinjured intervertebral disc that exists between adjacent vertebrae. Theimplant 900 can include opposing textured surfaces 902, 904 configuredto interface with a vertebral body. The implant 900 can further includean inner void 905 that can be filled with a biologic agent or other bonegrowth promoting material to stimulate natural bone growth that furtheranchors the implant 900 and fuses the vertebrae together.

Implant 900 can be initially anchored to adjacent vertebral bodies usingbone anchors 100 a, 100 b. As shown in FIG. 10, implant 900 can includeone or more lumens 1002 configured to receive sets of first and secondprobe components that form bone anchors 100 a and 100 b, as discussedabove. The lumens can be shaped to appropriately interface with theproximal heads 106, 108 of the first and second probe components,similar to the crimp head 300 and polyaxial receiving head 500 discussedabove. Implant 900 can further include a threaded lumen 1004 configuredto receive a set screw 906, which is shown in FIG. 9.

As illustrated in FIG. 11, which shows the configuration of the setscrew 906 and bone anchors 100 a, 100 b with the implant hidden, the setscrew 906 can include an interface portion 1102 that interfaces with,for example, the flat surface 204, 208 of the first and second probecomponents of each bone anchor 100 a, 100 b. The set screw 906, incombination with the implant lumen 1002, retains the proximal heads 106,108 of the first and second probe components 102, 104 in a fixedrelationship with each other.

FIG. 12 illustrates an exemplary embodiment of implant 900 in positionbetween two vertebrae 1202, 1204. Bone anchors 100 a, 100 b are shown inphantom implanted within the vertebrae. The bone anchors illustrated inFIG. 12 are retained in position by the lumens formed in implant 900 andthe set screw 906. Also shown in FIG. 12 is an exemplary applicator tool1206 as known in the art for inserting and adjusting the set screw 906.

Still another embodiment of the invention provides a bone anchor asdescribed above that further includes a rod section joined to eachproximal head of the first and second probe components. In such anembodiment, when the first and second probe components are joinedtogether, the associated rod sections can also be aligned to form acomplete spinal fixation rod. This rod can be attached to additionalbone anchors of the type described herein to create a complete spinalfixation assembly using fewer parts than was previously possible.

FIG. 13 illustrates an exemplary bone anchor 1300 including first andsecond probe components 1302, 1304 that are connected at their proximalends to first and second rod sections 1306, 1308. The connection caninclude a hinge portion 1310 in each rod section that allows the rodsections 1306, 1308 to rotate relative to the probe components 1302,1304. This rotation can be used to connect the rod sections 1306, 1308to additional bone anchors, or to collapse the bone anchor 1300, e.g.,for easier introduction to a surgical site. Hinge portion 1310 caninclude any mechanical hinge known in the art. In some embodiments,hinge portion 1310 can be a “living” hinge integrated into the materialof rod sections 1306, 1308. This can be accomplished, for example, byincorporating a different, more pliable material into the rod sections1306, 1308 in the area of hinge portion 1310. Alternatively, hingeportion 1310 can be formed by simply using a thinner portion of materialto allow bending. A notch or other deformation can also be included athinge portion 1310 to promote bending in a particular location, as shownlater in FIG. 22.

Referring to FIG. 14, an alternate view of bone anchor 1300 is shownillustrating the cross-sectional shape of the rod sections 1306, 1308.In some embodiments, the rod sections can form extensions of the probecomponents 1302, 1304. For example, in FIG. 14, each rod section 1306,1308 includes an external face 1402, 1404 that can have a convex shape,similar to the external faces of probe components 1302, 1304, asdiscussed above. Rod sections 1306, 1308 can each further include aninternal face 1406, 1408 that can be substantially linear, similar tothe internal faces of the first and second probe components. However, inother embodiments, the rod sections, and even the probe componentsthemselves, can have a variety of other cross-sectional shapes thatcomplement each other and are configured to mate together. Any of theseother cross-sectional shapes (e.g., half circles, interlocking ridges,diagonals, tongue and groove, etc.) are considered within the scope ofthe present invention.

FIGS. 15 and 16 illustrate the internal surfaces of exemplary probecomponents 1302, 1304 with connected rod sections 1306, 1308. Withreference to FIG. 15 in particular, probe component 1302 is very similarto the first probe component 102 discussed above. The probe component1302 includes an internal surface 1406 and a guide shoulder 1502configured to interface with probe component 1304. Probe component 1304,illustrated in FIG. 16, includes an internal surface 1408 and a matingedge 1602 configured to interface with internal surface 1406 and guideshoulder 1502 of probe component 1302.

FIG. 17 illustrates an embodiment of bone anchor 1300 implanted in avertebrae 1702. The probe components 1302, 1304 are implanted inside thevertebrae, and rod sections 1306, 1308 extend outside the vertebrae.Also shown is an exemplary embodiment of a crimp head 1704 that isconfigured to work with the bone anchor 1300. An alternate perspectiveview of bone anchor 1300 and crimp head 1704 is shown in FIG. 18 forclarity.

Crimp head 1704 is shown in isolation in FIG. 19. Similar to the crimphead 300 discussed above, crimp head 1704 can include clamping arms 1902to securely retain probe components 1302, 1304 in a fixed relationshipwith each other. Crimp head 1704, however, can also include anadditional set of clamping arms 1904 configured to retain the rodsections 1306, 1308 in a fixed relationship with each other. The sets ofclamping arms 1902, 1904 can be connected by a supporting portion 1906.Supporting portion 1906 can be configured to provide additional clampingforce to the rod sections 1306, 1308. In addition, supporting portion1906 can be configured to provide stress relief and support for thehinge portion 1310 after implantation.

The various embodiments disclosed herein can be combined as modularcomponents to create a complete spinal fixation assembly requiring fewercomponents and less complicated procedures to implant within a patient.An exemplary spinal fixation assembly 2000 is illustrated in FIG. 20.The assembly 2000 includes two bone anchors 1300 a, 1300 b havingconnected rod sections 1306 a, 1308 a, 1306 b, 1308 b. The anchors aresecured by crimp heads 1704 a and 1704 b. The rod sections are connectedto additional bone anchors 100 a, 100 b by being seated in the fixationelement receiving seats 128 a, 128 b and secured by crimp heads 300 a,300 b. The spinal fixation assembly 2000 can also serve as a foundationfor attaching various other spinal fixation accessories, such as one ormore transverse supporting members 2002. Crimp heads 1704 can also beprovided in transversely connected pairs, incorporating the transversesupporting feature. Transverse supporting members 2002 can be formedfrom any biocompatible material and, in exemplary embodiments, areformed from titanium or a titanium alloy. Many additional modularcombinations of the components disclosed herein are possible and all areconsidered within the scope of the present invention.

In addition, the bone anchors of the present invention can be easilyconfigured to provide anchoring in any application requiring securing acomponent or tissue to bone. For example, an exemplary bone anchor 2100of the present invention is shown in FIG. 21 functioning as a sutureanchor. Bone anchor 2100 includes first and second probe components2102, 2104 similar to bone anchor 100 discussed above. First and secondprobe components 2102, 2104 each further include a suture receivingportion 2106, 2108, which can be a bore formed through the probecomponent and configured to receive a threaded suture 2110 therethrough.Suture 2110 can then extend out of the cavity formed in bone 2112 and beutilized to accomplish any of a variety of tasks. In the embodimentillustrated in FIG. 21, the proximal heads of probe components 2102,2104 can be retained in a fixed relationship with each other by a ringclip 2114. Ring clip 2114 provides the same retaining function as thecrimp heads and polyaxial receiving heads discussed above, but has alower profile design that minimizes the protrusion of the bone anchorfrom the bone surface.

The present invention also provides methods for using the bone anchorsdisclosed herein. Bone anchors of the present invention can be utilizedin a variety of procedures, including open surgery and minimallyinvasive procedures. In minimally invasive procedures, each bone anchorcomponent must be delivered to the surgical site through, for example,an appropriately sized and shaped port similar to the port 2202illustrated in FIG. 22. In order to facilitate delivery throughrestricted spaces such as port 2202, bone anchor components of thepresent invention can include features to reduce their size or areafootprint. Exemplary features include the hinge portion 1310 discussedabove and illustrated in FIG. 22. Hinge portion 1310 of bone anchor 1300in FIG. 22 utilizes a thinner portion of material and a pre-formed notch2204 to allow the bone anchor to be collapsed as shown in the figure.Once at the surgical site, the rod sections 1306, 1308 can be rotatedback into position to connect with other bone anchor components to forma spinal fixation assembly like that shown in FIG. 20. In addition, theprobe components and attached rod sections can be delivered together, asshown in FIG. 22, or separately.

Turning now to FIG. 23, a method of anchoring an implant to bone isprovided that includes the step of inserting a first probe component ormember into a cavity formed in bone [step 2302]. The probe member can beinserted straight into the cavity formed in bone, or along an arcedpath.

In the embodiments discussed above, inserting the first probe member 102first can be important, because the guide shoulder 124 can direct thesecond probe member as it is inserted. In some other embodiments,however, the first probe member may not include a guide shoulder 124. Insuch embodiments, the divergence of the distal tips can be accomplishedthrough the alignment and fixed relationship of the proximal heads ofthe probe members alone. In these embodiments, it does not matterwhether the first probe member or the second probe member is insertedfirst.

Following insertion of the first probe member, a second probe componentor member can be inserted into the cavity formed in the bone adjacent tothe first probe member [step 2304]. This can be accomplished, forexample, by sliding the second probe member along an internal surface ofthe first probe member such that a mating edge of the second probemember interfaces with a guide shoulder formed on the internal surfaceof the first probe member. The guide shoulder can cause the distal tipof the second probe member to diverge from the distal tip of the firstprobe member as the second probe member is inserted into the bonecavity.

Following insertion of both probe members, the proximal heads of thefirst and second probe members can be aligned [step 2306]. If the probemembers include any connected rod sections, these can be aligned as welland rotated into position to connect with additional bone anchors. Inaddition, any other spinal fixation elements that need to be mated tothe bone anchor can be seated, for example by seating the element in thefixation element receiving seat formed by the proximal heads of thefirst and second probe members.

Finally, a crimp head can be applied to the aligned proximal heads ofthe first and second probe members to retain them in a fixedrelationship with each other [step 2308]. The crimp head can furtherretain any spinal fixation elements seated in, for example, the fixationelement receiving seat of a bone anchor.

In embodiments that utilize an implant for fusing two vertebral bodiestogether, a polyaxial receiving head, or any other receiving headassembly having a closed lumen, steps 2302-2308 can be performed afterpositioning the implant, receiving head, or other receiving headassembly in position over a hole formed in the bone. Each probe membercan then be inserted through both the implant, receiving head, or screwassembly, as well as the bone. Following insertion, and in place of step2308 above, a set screw can be applied to retain the proximal ends ofthe probe members in a fixed relationship with each other and to retaina spinal fixation element to the bone anchor.

Bone anchors of the present invention provide an additional benefit overprior art anchors in that they are easily removable following spinalfixation and natural healing. To remove the bone anchors, the steps ofthe method illustrated in FIG. 23 are simply reversed. For example, anycrimp head, polyaxial bone screw, implant set screw, or other accessorycan be removed to free the first and second probe members from oneanother. The second probe member can then be removed from the cavityformed in the bone by rotating the second probe member such that itsdistal tip converges with the distal tip of the first probe member. Thismovement will disengage the bone engaging edge of the second probemember, thereby allowing its removal from the cavity. The first probemember can then be similarly repositioned to disengage its bone engagingedge and subsequently removed from the cavity.

All papers and publications cited herein are hereby incorporated byreference in their entirety. One skilled in the art will appreciatefurther features and advantages of the invention based on theabove-described embodiments. Accordingly, the invention is not to belimited by what has been particularly shown and described, except asindicated by the appended claims.

1. A bone anchor member configured to be implanted in bone, comprising: a first probe component in the form of an elongate member having a proximal head and a distal tip, a bone engaging edge having a plurality of barbs, an opposed edge, an external surface, and an opposed internal surface having a guide shoulder formed thereon; and a second probe component in the form of an elongate member having a proximal head and a distal tip, a bone engaging edge having a plurality of barbs, a mating edge having a profile complementary to the guide shoulder and being configured to be seated along the guide shoulder, an external surface, and an opposed internal surface; wherein the first and second probe components are configured to be assembled to form a bone anchor such that the barbed bone engaging edges of the first and second probe are disposed opposite to one another, the mating edge of the second probe component is seated along the guide shoulder of the first probe component, and a distal tip of each probe component diverges away from a central longitudinal axis of the bone anchor.
 2. The bone anchor of claim 1, wherein the first and second probe members are curved.
 3. The bone anchor of claim 1, wherein the external surfaces of the first probe component and the second probe component are convex.
 4. The bone anchor of claim 1, wherein the internal surfaces of the first probe component and the second probe component are substantially linear.
 5. The bone anchor of claim 1, further comprising a crimp head configured to retain the proximal heads of the first probe component and the second probe component in a fixed relationship with each other.
 6. The bone anchor of claim 5, wherein each proximal head has a recess formed therein configured to seat a spinal fixation element.
 7. The bone anchor of claim 1, further comprising a polyaxial receiving head configured to retain the proximal heads of the first probe component and the second probe component in a fixed relationship with each other.
 8. The bone anchor of claim 1, wherein each of the first probe component and the second probe component further comprise a rod section joined to the proximal head thereof, wherein each rod section is joined to form a spinal fixation element.
 9. The bone anchor of claim 8, further comprising a crimp head configured to retain the proximal heads and rod sections of the first probe component and second probe component in a fixed relationship with each other.
 10. The bone anchor of claim 1, further comprising an implant configured to fuse two vertebral bodies together, wherein the implant comprises at least one lumen formed therein and configured to receive the first probe component and the second probe component.
 11. The bone anchor of claim 10, further comprising a set screw configured to engage a threaded lumen formed in the implant and secure the first probe component and the second probe component in relation to the implant.
 12. The bone anchor of claim 1, wherein the first probe component and the second probe component are formed from any of titanium, a titanium alloy, polyether ether ketone (PEEK), and reinforced PEEK.
 13. The bone anchor of claim 1, wherein the first probe component and the second probe component are formed from a radiolucent material.
 14. An implantable bone anchor, comprising: an elongate member having a proximal head with a fixation element receiving seat and dual divergent distal tips; and opposed bone engaging edges having a plurality of barbs formed thereon; wherein the bone anchor is formed of separate matable probe components; and wherein each probe component has one of the divergent distal tips.
 15. The bone anchor of claim 14, wherein each probe component is curved along its length from the proximal head to the divergent distal tip.
 16. The bone anchor of claim 14, wherein each probe component is mated to the other along at least a portion of an internal surface that is opposed to one of the bone engaging edges.
 17. A method of anchoring an implant to bone, comprising: inserting a first probe member into a cavity formed in bone, the first probe member being a curved, elongate member having a distal tip and a proximal head; and inserting a second probe member into the cavity adjacent to the first probe member, the second probe member being a curved, elongate member having a distal tip and a proximal head, the first and second probe members mating to one another such that the heads of the first and second probe members are aligned and the distal tips of the first and second probe members diverge.
 18. The method of claim 17, wherein inserting the second probe member comprises sliding the second probe member along a guide shoulder formed in the first probe member to properly align the first probe member and the second probe member in the cavity.
 19. The method of claim 17, further comprising the step of applying a crimp head to the proximal heads of the first probe member and the second probe member to retain the proximal heads in relation to each other.
 20. The method of claim 17, wherein the first probe member and the second probe member each further comprise a rod section connected to the proximal head, the method further comprising the step of aligning the rod sections of the first probe member and the second probe member to assemble a spinal fixation element.
 21. The method of claim 20, further comprising the step of applying a crimp head to retain the proximal heads and the rod sections of the first probe member and the second probe member in relation to each other. 